BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect data to help researchers better understand the various causes of obesity, which may lead to the development of new obesity treatment options.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida
• Collaborator: Sanford-Burnham Medical Research Institute
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Age 18-65 years, inclusive

• Men and women

• Able to provide written, informed consent

• Weight stable (± 3 kg) during the 3 months prior to enrollment

• BMI ≤ 25 kg/m2 for lean subjects or ≥ 30 kg/m2 for obese subjects

Exclusion Criteria:

• 1) Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or Chronic obstructive pulmonary disease (COPD), g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder

• Pregnant or nursing women

• Presence of clinically significant abnormalities on electrocardiogram;

• Smoking

• Known hypersensitivity to nesiritide or any of its excipients

• Poor intravenous access

• Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.

• Your blood pressure at your screening visit is less than or equal to 100/60 or greater than or equal to 160/100.